Nested expandable sleeve implant

ABSTRACT

An expandable implant for treating bone preferably in a minimally invasive manner includes a preferably cylindrical core element extending along a longitudinal axis and preferably a plurality of nestable, expandable sleeves extending along a longitudinal axis for placement radially about the core element. The plurality of nestable sleeves are sequentially insertable over the core element in such a manner that a first nestable sleeve is inserted over the core element and each subsequently inserted nestable sleeve is received between the core element and the previously inserted nestable sleeve such that the insertion of each additional sleeve causes each previously inserted sleeve to outwardly expand.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/921,698, filed Sep. 9, 2010, which is the National State ofInternational Application No. PCT/US2009/036659, filed Mar. 10, 2009,which claims the benefit of U.S. Provisional Application No. 61,036,766,filed Mar. 14, 2008, the contents of which are hereby incorporated byreference as if set forth in their entireties herein.

TECHNICAL FIELD

The present application relates generally to orthopedics, and morespecifically, to bone augmentation using expandable bone augmentationimplantation devices. The device of the present application may beappropriate for use in minimally invasive surgical techniques, and inparticular for use in vertebra, long bones, etc.

BACKGROUND

As bone ages the cancellous bone tends to become less dense and moreosteoporotic. As bone becomes less dense and more osteoporotic it ismore prone to fractures, collapse and being unable to support loads. Tostrengthen such bone, methods, instruments, implants and devices havebeen developed to augment and strengthen bone. These devices howeverhave shortcomings Most compression fracture fixation devices areinflatable, such as balloon expandable devices used in vertebralplasty.Such methods, instruments, devices and implants include no way ofcentering a load bearing element(s) and centrally applying an expansionmechanism to keep the axis intact. Also absent in known methods,instruments, devices and implants is a structural support for suchdevices other than hydraulic pressure. It would be advantageous toconstruct a percutaneous bone augmentation solution that provides bothstructural support as well as a concentrically applied expansion.

SUMMARY

In one embodiment, the present invention is directed to an expandableimplant preferably for treating bone in a minimally invasive manner. Theimplant may comprise a core element extending along a longitudinal axis,and one or more of sleeves, preferably a plurality of sleeves, placedradially about the core element. The sleeves may be nestable andexpandable. The plurality of sleeves may be sequentially insertable overthe core element in such a manner that a first sleeve is inserted overthe core element and each subsequently inserted sleeve is receivedbetween the core element and the previously inserted sleeve such thatthe insertion of each additional sleeve causes each previously insertedsleeve to outwardly expand. The expandable implant and/or core elementmay be substantially cylindrically shaped, or comprise other shapes thatmay have at least one flat surface or side, such as, for example, ahexagon, square, octagon, trapezoid or other polygonal shapes. Theexpandable implant may also be asymmetrically shaped or alternativelysymmetrically shaped.

The expandable implant may further comprise an expandable membrane toprovide radial compression to the expandable sleeves. The sleeves maycomprise ribs and spacers. The sleeves, for example may extendcircumferentially about a central axis to form a hollow cylinder ortube. Alternatively, the ribs, spacers or other structural elementsforming the sleeve may extend less than the entire circumference aboutthe longitudinal axis so that the resultant expandable implant may beasymmetrical about its axis. The sleeves, and structural elementsforming the sleeve, may comprise a one piece integral unit formed ofribs and spacers connected by flexible struts. The sleeves and/orexpandable implant in its expanded condition may be cylindricallyshaped, or the implant may form at least one flat surface or side, aswould result from an implant forming, for example, a substantiallyhexagonal, square, trapezoidal, octagonal or other polygonal shapedimplant.

The core element and sleeves of the expandable implant may besubstantially the same length, or preferably the sleeves will beslightly shorter in length than the core element. The sleeves and coreelement may have at least one of a projection and recess so that thesleeves interdigitate with each other and the core element. The insidediameter or cross-sectional shape of the expandable sleeve in theunexpanded natural state may be slightly less than the diameter or crosssectional shape and size of the proximal end of the core element. Such aconfiguration may permit the sleeve to expand slightly as it is fittedover the core element which may assist in securing the sleeve inposition on the implant.

In another embodiment the present invention may comprise a kitcomprising one or more core elements having a longitudinal axis, and oneor more sleeves for placement radially about the core element, whereinthe sleeves are sized and configured to be sequentially insertable overthe core element in such a manner that a first sleeve is inserted overthe core element and each subsequentially inserted sleeve is insertedbetween the core element and the previously inserted sleeve such thatthe insertion of each additional sleeve causes each previously insertedsleeve to outwardly expand. The core element has a distal end and aproximal end, and the sleeves have a distal end and a proximal end,wherein the distal end of the sleeve is configured and sized to beinserted first over the proximal end of the core element and moved overthe core element so that the proximal end of the sleeve is substantiallyaligned with the proximal end of the core element, preferably while thecore element, and or core element and previously placed sleeves, arepositioned within bone. The sleeves are preferably nestable and radiallyexpandable, and preferably interlock with each other and/or the coreelement.

In another embodiment the present invention may comprise a system or kitfor treating bone preferably in a minimally invasive manner, the systemincluding (i) providing a core element having a length extending along alongitudinal axis and further including a proximal end, a distal end andan instrument engagement feature at the proximal end; (ii) providing aninsertion instrument that includes a cannulated barrel, a rod elementlocated within the cannulated barrel, the rod element including a coreelement engagement feature at the distal end; and (iii) one or moresleeve elements, preferably nestable and expandable sleeve elementspositionable along the exterior of the rod element in end-to-end fashionand within the cannulated barrel, wherein the instrument engagementfeature of the proximal end of the core element is engageable to thecore element engagement feature at the distal end of the rod element,and wherein the sleeve elements from within the cannulated barrel areadvanceable along the rod element and over the core element, wherebyadvancing at least one additional sleeve element from within thecannulated barrel along the rod element and between the core element andthe previously inserted sleeve element causes the radial expansion ofthe previously inserted sleeve element, wherein the radius of theimplant expands as each additional sleeve element is applied about thecore element.

Both the core and sleeve elements may be provided in a variety oflengths. For example, a number of core elements of different length maybe provided, and a number of insertion instruments containing differentlength sleeve elements corresponding to the different length coreelements may be provided. The core and sleeve elements may, for example,start at 2 cm lengths and increase in increments of 2 mm to provide anassortment of sizes for the surgeon to choose from during a surgicalprocedure. Each insertion instrument may have more than a sufficientnumber of sleeve elements so that the surgeon can custom tailor the size(diameter, cross-sectional size, girth or thickness) of the implantduring the surgical procedure. Each insertion instrument may have adifferent or the same number of sleeve elements provided, and a surgeonmay be able to load the sleeve elements into the insertion instrumentprior to surgery based upon the sizing requirements for the particularprocedure anticipated. Alterations in the number and size of the sleeveelements loaded into the insertion instrument may be accommodated duringthe procedure.

A method of treating bone in a minimally invasive manner is alsodescribed. The method may include one or more of the following steps:(a) forming an access path to a bone to be treated, for example, avertebral body; (b) providing a core element having a length extendingalong a longitudinal axis and further including a proximal end, a distalend and an instrument engagement feature at the proximal end; (c)providing an insertion instrument that includes a cannulated barrel, arod element located within the cannulated barrel, and one or more sleeveelements, preferably nestable and expandable sleeve elements, the rodelement further including a core element engagement feature at thedistal end, wherein the plurality of sleeve elements are disposed inend-to-end fashion along the rod element and within the cannulatedbarrel; (d) engaging or attaching the instrument engagement feature atthe proximal end of the core element to the core element engagementfeature at the distal end of the rod element; (e) inserting the coreelement through the access path and into the bone to be treated; (f)advancing a sleeve element from within the cannulated barrel along therod element and over the core element; (g) preferably advancing at leastone additional sleeve element from within the cannulated barrel alongthe rod element and between the core element and the previously insertedsleeve element, thereby causing the radial expansion of the previouslyinserted sleeve element, wherein the radius of the implant expands aseach additional sleeve element is applied about the core element; (h)disengaging the insertion instrument from the core element; and (i)removing the insertion instrument from the patient to be treated. In themethod of treating bone, the core element may be placed in the bone tobe treated and thereafter the insertion instrument may be attached tothe core element, or the core element and insertion instrument first maybe attached to each other and the assembly placed in the patienttogether, with the core element placed in the bone to be treated and theproximal end of the insertion instrument extending from the patient.

In another embodiment an expandable implant for treating tissuepreferably in a minimally invasive manner is provided, the implantincludes a preferably cylindrical core element extending along alongitudinal axis and preferably a plurality of nestable, expandablesleeves extending along a longitudinal axis for placement radially aboutthe core element. The plurality of nestable sleeves are sequentiallyinsertable over the core element in such a manner that a first nestablesleeve is inserted over the core element and each subsequently insertednestable sleeve is received between the core element and the previouslyinserted nestable sleeve such that the insertion of each additionalsleeve causes each previously inserted sleeve to outwardly expand.

The implant, system, kit and method may be applied to any number ofbones and bone conditions and treatments and even as preventativemeasures to prevent bone compression or fractures. For example theimplant, system, kit and method may be applied to treat vertebralcompression fractures or metaphyseal fractures in long bones, or totreat other bones, or for non-medical applications. The implant, system,kit and method may be used to fill voids or cavities created in bone orother tissue, and may be used to compact cancellous bone to form andfill a cavity in the bone, and may be used to move bone, for example,cortical bone, including but not limited to vertebral endplates torestore vertebral height and angle.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofpreferred embodiments of the application, will be better understood whenread in conjunction with the appended drawings. The drawings, examplesand embodiments described within this specification are for the purposesof describing and enabling the expandable implant system, kit and methodof use, and are to be understood as illustrative and exemplary ofstructures, features, aspects and methods of using the presentinvention, and not as limiting the scope of the invention. It should beunderstood that the application is not limited to the precisearrangements, configurations and instrumentalities shown. In thedrawings:

FIG. 1 illustrates a front top perspective view of an expandable implantin accordance with the present invention;

FIG. 2 illustrates a back top perspective view of the expandable implantof FIG. 1;

FIG. 3 illustrates a front elevational view of the expandable implant ofFIG. 1;

FIG. 4 illustrates a cross sectional side view of the expandable implantof FIG. 1;

FIG. 5 illustrates a cross sectional view of the core element of theexpandable implant shown in FIGS. 1-4;

FIG. 6 illustrates a cross sectional view of a sleeve element of theexpandable implant shown in FIGS. 1-4;

FIGS. 7 and 8 respectively illustrates a top elevation view of a rib anda spacer of the sleeve element;

FIG. 9 illustrates a cross sectional view of an insertion instrumentwith a plurality of expandable sleeves mounted therein;

FIG. 10 illustrates a cross-sectional view of another embodiment of anexpandable implant in accordance with the present invention;

FIG. 11 illustrates a cross-sectional view of the expandable implant ofFIG. 10;

FIG. 12 illustrates a front top perspective view of another embodimentof an expandable implant in accordance with the present invention;

FIG. 13 illustrates a front elevation view of the expandable implant ofFIG. 12; and

FIG. 14 illustrates a view of one embodiment of the expandable implantinserted into a vertebral body.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The embodiments implants, systems, kits, methods, and examples describedwithin this specification are to be understood as illustrative andexemplary of the structures, features and aspects of the implants,systems, kits and methods of the present invention, and not as limitingthe scope of the invention. The features, structures, aspects and stepsof the implant, system and method may be used singularly, alternativelyor together as desired or appropriate. Certain terminology used in thefollowing description is for convenience and description only and is notbe used in a limiting manner or to be limiting in nature. The words“right”, “left”, “lower” and “upper” designate directions in thedrawings to which reference is made. The words “inwardly” and“outwardly” refer to directions toward and away from, respectively, thegeometric center of the device and designated parts thereof The words,“anterior”, “posterior”, “superior”, “inferior” and related words and/orphrases designate preferred positions and orientations in the human bodyto which reference is made and are not meant to be limiting in nature.The terminology includes the above-listed words, derivatives thereof andwords of similar import.

In accordance with the present invention, and in reference to FIGS. 1-4,an expandable bone augmentation implant 100 is provided. The implant 100preferably includes a core element 110, in this embodiment morepreferably a substantially cylindrical core element, capable of beinginserted into a bony void such as, for example, within a compressionfracture of the metaphyseal portion of a long bone, vertebralcompression fracture, etc., and preferably will provide structuralsupport to the bone or other tissue in which it is implanted. The coreelement 110 may be solid or cannulated and has a longitudinal axis 112.The lumen or bore 118 may extend partially or completely down the lengthof the core element 110. A full length cannulation may permit andfacilitate placement of the core element and implant into position overa guide wire. In a preferred embodiment, the core element 110 includes abullet-nosed, rounded, or otherwise contoured tip 111 at its distal end110 a. The proximal end 110 b of the core element 110 preferablyincludes an instrument engagement feature 115, such as a length ofthreading on the core element 110, for example, a length of threading112 along the proximal portion 118 a of the interior bore 118, to enableease of insertion. Alternatively, or additionally, the proximal portion118 a of the interior bore 118 may be sized and shaped to receive aprojection on the insertion instrument in a snap fit, or the coreelement may attach to the insertion instrument by other attachmentmeans. Alternatively, the instrument engagement feature 115 may assumealternative forms, such as a feature (not shown) on the exterior surface117 of the core element 110.

The implant core element is preferably formed from a material ofsufficient structural integrity to support physiological loads that willbe applied to the bone or tissue to be treated. The thickness,configuration and material of the core element will depend upon the boneor tissue to be treated, the location of the implant within the bone ortissue to be treated, the size of the patient and the forces that may beapplied to the implant in use. Suitable materials for the core elementmay be titanium, titanium alloys, stainless steel, ceramics, compositematerials, polymers, PEEK and/or other biocompatible materials.

The implant 100 preferably includes one or more sleeve elements 120 sothat, in use, the implant 100 is preferably radially expandable bysequentially inserting sleeve elements 120 that stack or nest around theimplant core element 110. Preferably the sleeve elements are radiallyexpandable. As shown, a first sleeve 120 a may be slid over the coreelement 110 using an insertion instrument, such as, inserter instrument200, as is discussed in detail below. A second sleeve 120 b may be slidover the core element 110 between the previously inserted sleeve element120 a and the core element 110 such that as the second sleeve 120 b isinserted between the core element 110 and the first sleeve 120 a, thefirst sleeve 120 a expands radially. As a third sleeve element 120 c isslid over the core element 110 between the second sleeve element 120 band the core element 110, the first and second sleeves 120 a, 120 bradially expand. Any number of sleeve elements 120 can be chosen toprovide the desired final shape and size of the implant 100. As aresult, the implant 100 provides a preferably, structurally rigidimplant 100 preferably capable of insertion through a percutaneousaccess path utilizing a preferably minimally invasive procedure andwhich undergoes incremental expansion to a larger implant volume tothereby fill a void or cavity in bone or tissue, and preferably supportthe loads applied across the bone or tissue, act as supplementalfixation for other hardware or implants, such as, for example, screws orother fasteners, as well as, in some cases, restore the desired heightand shape of a collapsed bone or tissue, for example a collapsedvertebral body. The expansion of the implant may compact cancellousbone, and may restore the height and shape of a collapsed bone by movingthe cortical bone.

The structure and configuration of the core element 110 will bedescribed in more detail as will the sleeve element and the interactionbetween the core element 110 and sleeve element 120 to form theexpandable implant 100. While the core element 118 in the embodiment ofFIGS. 1-5 has been shown and described as being substantiallycylindrical in shape and having a diameter and a length, it is to beunderstood that the cross sectional shape of the core element may benon-circular, and may have a cross-sectional shape that provides a flatsurface or side, such as, for example, a square, hexagon, octagon,trapezoid or other polygon shape. These and other shapes arecontemplated for use for the core element. The term “diameter” when usedwhen referring to a non-circular cross-section refers to thecross-sectional size, width and thickness as may be appropriate in thegiven context.

The core element may have a first diameter 116 or cross-sectional shapealong a substantial portion of its length. The proximal end 110 b of thecore element may have a beveled, chamfered or blunt edge 114 tofacilitate sliding of the sleeve elements onto the core element. Thedistal end 110 a of the core element 110 may be enlarged to form a stop111 a for one or more of sleeve elements 120. The core element 110 maybe provided with one or more recesses 119 on its exterior surface 117.The recesses 119 permit and facilitate engaging and securing the sleeveelements 120 to the core element 110 as will be described in more detailbelow. The recesses 119 may be provided circumferentially around theexterior surface 117 of the core element, or at select locations alongthe circumference of the exterior surface 117 of the core element.Recesses 119 may be provided on the distal portion as illustrated inFIG. 5, or alternatively, or in addition to, at the proximal or middleportions of the core element 110. Recesses 119 may include otherfeatures and configurations to permit and facilitate the engagement andsecuring of the sleeve elements on the core element.

The core element may further include one or more expandable bands 136(not shown) that extend circumferentially around the core element.Expandable bands 136 may extend around the proximal, middle and/ordistal portions of the core element 110. The expandable bands 136 mayassist in providing a radial compression force against the sleeveelements 120 as the sleeve elements are slid into position on the coreelement 110. The sleeve element 120 preferably would be positioned underthe expandable bands 136. In addition, the core element may include oneor more longitudinal grooves (not shown) to assist and facilitate thepositioning and orientation of the sleeve elements as they move over thecore element.

The core element 110 preferably is sized and shaped to permit andfacilitate insertion into bone through a minimally invasive opening,such as, for example, through a puncture, cannula or small incision. Inone embodiment, the outside diameter of the core element may beapproximately 6 mm, with the distal tip 110 a being approximately 8 mmin diameter. Other diameters and configurations of the core element arecontemplated. The core element 110 a may be provided in a variety ofsizes, for example, a plurality of different lengths and/or diameters,and/or cross-sectional shapes, appropriate for the different bonesintended to be treated. In one embodiment, the core element may have alength of approximately 2 centimeters long. Numerous core elements maybe provided in different lengths so that an implant 100 appropriate forthe bone to be treated can be assembled via components provided in akit, or can be assembled in the operating room as part of a system toform an appropriate size implant. The different size core elements canbe provided in lengths that increase in preselected increments, such as,for example, 2 mm, so that the core elements may be 2 cm, 2.2 cm, 2.4cm, 2.6 cm, etc., in length. In this manner, the appropriate lengthimplant can be selected for the bone to be treated. The diameter orcross-sectional size of the core elements can also be provided in sizesthat increase in preselected increments, such as, for example, 6 mm, 8mm, 10 mm, etc., diameters.

In reference to FIGS. 1-4, and 6-11, the sleeve elements 120 arepreferably expandable. The sleeve elements 120 preferably have anopening at the distal end that communicates with a hollow interior. Thesleeve elements also preferably have an opening at the proximal end incommunication with the hollow interior so that the sleeve elements arepreferably hollow tubes having a length, an inside diameter DI, a shellthickness t and an outside diameter DO. The proximal end of the sleeveelement may not have an opening and may be closed, partially closed,partially open and/or formed with a lip, flange or shoulder thatpartially obstructs the proximal opening and may form a stop member thatprevents the sleeve from being inserted too far over the core element.The sleeve elements and core element are preferably configured such thatthe diameter or cross section of the exterior surface 117 of the coreelement 110 is approximately the same size or slightly larger than theinside diameter DI or cross-section of the sleeve member so thatpreferably the sleeve element has to expand slightly to fit over thecore element. In this manner a compressive radial force is appliedagainst the core element by the sleeve element to assist in securing thesleeve element to the core element.

In reference to FIGS. 1-4 and 6-11, the sleeve elements may include aplurality of ribs 122 and spacers 124. Ribs 122 and spacers 124 arepreferably formed of any biocompatible material of sufficient structuralintegrity and strength to support physiological loads applied thereacross. Such materials may include, for example, stainless steel,titanium, titanium alloys, metals, metal alloys, ceramics, polymers,PEEK, composite materials, allograft or autograft bone. The ribs 122 andspacers 124 may be interconnected by an expandable membrane 126 or meshformed of a metal, polymer or elastomeric material. The expandablemembrane 126 is attached to the ribs 122 and spacers 124 to apply aninward radial compressive force. The membrane 126 may be attached to anysurface of the ribs 122 or the spacers 124 or pass through the bodies ofthe ribs 122 and the spacers 124. The membrane 126 may be a uniformelement, or comprised of segmental portions that interdigitate betweenthe ribs 122 and the spacers 124. The membrane 126 may permit uniform orvariable expansion between the ribs 122 and spacers 124 in order to bestfill voids in bone and support loading. One or more expandable membranes126 may be provided with the sleeve elements 120. Expandable membranes126 may be present in addition to, or alternatively in place of,expandable bands 136.

The sleeve element 120 may also comprise ribs and spacers interconnectedby flexible struts that extend between each rib and spacer. The flexiblestruts permit expansion between the ribs and spacers. The sleeve elementmay be a one piece integral design of the ribs, spacers and struts andmay be machined from a single piece of material. The flexible struts maypermit controlled expansion between each rib and spacer to permitnon-uniform expansion and result in a non-circular cross-sectional shapethat may have at least one flat surface or side. Having a flat side orsurface may be advantageous in certain procedures, such as, for example,expanding vertebral bone where the flat surface can be oriented to beparallel to the end plates of the vertebra to apply pressure toreorient, expand and support the vertebra end plates.

The ribs 122 may have dog bone shape as illustrated in FIG. 7 or anyother suitable shape. The spacers 124 may have the shape illustrated inFIG. 8 or any other suitable shape. The ribs and spacers may have shapesthat correspond and compliment each other as shown, ornon-corresponding, non-complimentary shapes. The sleeve element isformed of numerous ribs 122 and spacers 124 to preferably permit thesleeve to be flexible and expandable. The sleeve also may be formed ofonly ribs or only spacers, each having substantially the same size andshape, or same shape but different sizes.

The sleeve elements 120 may be approximately 1 mm in thickness, althoughother thickness are contemplated. The thickness of the sleeve elements,the ribs and the spacers may have a relatively uniform thickness, andmay be relatively flat. Alternatively, the sleeves, ribs and spacers mayhave a relatively non uniform thickness, and may be, for example, wedgeshaped. Alternatively, or additionally, the exterior surface of thesleeves, rib or spacer may be curved, as well as the internal surface.The exterior surface 128 of the sleeve element may have a recess 139while the interior surface 129 may have a projection 138. The projection138 on the sleeve element 120 will preferably engage and interlock withthe recess 119 formed in the core element 110, or the recess 139 formedin an adjacent sleeve element 120. The projections 138 and recesses 139may be formed on the ribs 122, the spacers 124 or both. The projections138 and recesses 139 may extend only partially across the width of, orthe entire width of, the ribs and spacers. The projections 138preferably will snap fit into the recesses 119, or recesses 139. In thismanner, the expandable sleeve elements are coupled to the core elementand preceding sleeve elements to provide a structurally integratedimplant to support loads experienced in bones or other tissue.

The recesses 119 and 139 and corresponding projections 138 may betriangularly shaped as illustrated in FIGS. 4-6 to facilitate theprojections 138 sliding into the recesses 119, 139 as the sleeves moveover the core element. The shape of the distal portion or wall 146 ofthe recesses 119, 139, and the wall 147 on the projections 138preferably form a stop mechanism 145 to prevent the sleeve element fromextending beyond the core element or previously placed sleeve elements.Features may be provided in the recesses 119, 139 and the projections138 to facilitate the locking of the sleeve element to the core element,or the preceding sleeve element. The projections and recesses on thecore element and sleeve elements may be reversed so that a projection isformed on the exterior surface of the core element and/or sleeveelement, and recesses are formed on the interior surfaces of the sleeveelements. The recesses and projections may be triangularly shaped with awall substantially perpendicular to the length of the core elementand/or sleeve element as illustrated in FIG. 4, or other shapes may beutilized.

Alternatively or additionally, other features may be provided on thecore element and sleeve element to couple the sleeve elements to eachother, or the core element. For example, as shown in FIG. 10, the sleeveand core element may be provided with a bump 150, preferably rounded,just distal of the recess 119, 139; and a dimple 152, preferablyrounded, just distal of the projection 138, to receive the bump toassist in engaging the sleeve to the core element.

The implant 100 may be inserted via an insertion instrument. As bestshown in FIG. 9, a preferred embodiment of the insertion instrument 200is shown. The insertion instrument 200 is preferably configured for usewith the implant 100 and may be specifically adapted for a minimallyinvasive surgical method. The instrument 200 preferably includes ahollow barrel 210 and a rod 220 preferably centered radially within thebarrel 210. The rod 220 includes a core element engagement feature 225at its distal end, such as, for example, exterior threading or a stardrive, capable of mating with the instrument engagement feature 115 onthe core element 110. The sleeve elements 120 are preferably housedalong the rod 220 in end-to-end fashion and are capable of beingadvanced through the barrel 210 and along the rod 210. In oneembodiment, the instrument 200 is used to direct and place the coreelement 110 within bone, preferably a collapsed vertebral body. Sleeves120 are passed through the barrel 210 and along the rod 220 and over theimplanted core element 110 as discussed above, such as by a plungingmechanism 230. The interior of the sleeves 120, preferably the interiorof the distal ends of the sleeves 120, can be configured to snap ontothe distal end of core element 110 to secure the sleeve 120 to coreelement 110, or to secure sleeve 120 a to sleeve 120 b, etc. When thesurgeon has obtained the desired radial volume or size of the expandableimplant 100, the surgeon stops advancing additional sleeves 120 andreleases the engagement feature 225 from the engagement feature 115.

Referring to FIGS. 1, 4 and 6, in a preferred embodiment, the sleeves120 preferably include a ramped nose 121 at their distal end thatpermits or facilitates the sleeve 120 that is being inserted or urgedonto core element 110, after another sleeve 120 is already positioned onthe core element 110, to radially expand the sleeve or sleeves 120already positioned on the implant to accommodate the new sleeve 120. Theramped nose 121 on the distal end of the sleeve 120 is not limited tothe shape shown and the sleeves 120 may be arranged and shaped in nearlyany manner, or the rod 220 may be constructed in nearly any manner topermit the sleeves 120 to radially expand as additional sleeves 120 areinserted onto the distal end of the core element. For example, each ofthe sleeves 120 may include a ramp 135 that is angled opposite of theramped nose 121 to accommodate one sleeve 120 sliding beneath anothersleeve 120 and onto the core element 110. The ramped nose 121 on thesleeve 120 may also facilitate the sleeve sliding underneath theexpandable bands 136, if such expandable bands 136 are provided on thecore element. The presence of longitudinal grooves in the core elementmay also facilitate the sliding and alignment of the sleeve elements onthe core element and each other, and the longitudinal grooves mayfurther assist and facilitate the sleeves sliding underneath theexpandable bands 136.

The sleeves 120 may be provided preloaded in the insertion instrument.Alternatively, the sleeves may be selected and loaded just prior toinsertion into the patient, for example, in the operating room, or justprior to the procedure, by the doctor surgeon or staff workers. Thesleeves may be supplied in a variety of lengths and thicknesses. In oneexemplary embodiment, the sleeve may be approximately 18 mm long, aninside diameter of approximately 5.5 mm and a shell thickness t ofapproximately 1 mm so that each additional sleeve increases thethickness, height, diameter or cross sectional size of the expandableimplant 100 by approximately 2 mm. For example, the expandable implantin FIG. 1 having a core element diameter of approximately 6 mm, andthree expandable sleeves of approximately 1 mm in thickness would have adiameter of between approximately 12 and 13 mm when accounting for thespacing and gaps between the sleeves. The sleeves may also be providedin different lengths, and numerous sleeves of different lengths may beprovided in a kit or system in order to form expandable implants ofdifferent lengths and heights.

The insertion instrument may be loaded with multiple sleeves all havingthe same size and configuration of ribs and spacers resulting insleeves, in the unexpanded condition, of the same size (length anddiameter). As the same sized sleeves are inserted over the core, theearlier placed sleeves will expand such that each respective stackedsleeve in the expanded condition will be a different diameter(cross-sectional size). In the expandable implant, the first placedexpandable sleeve will radially expand the most, and the spacing betweenthe ribs and spaces will be larger on the first sleeve member. That is,the spacing between the ribs and spacers after insertion on the coreelement will vary by the level of the stacked sleeve. In the embodimentof FIG. 1 the gap or space between each rib and spacer will be about0.45 mm in the second row and about 0.58 mm in the third row.Alternatively, different sized sleeves (length and/or diameter) can beloaded into the insertion instrument. If different length sleeves areused to construct the expandable implant, the sleeves can be constructedso that as they are stacked the distal end provides a tapered or bluntdistal end. For example, the sleeves can be constructed so that therecesses 139 and projections 138 are configured so that the distal endbeyond the projection on each subsequently inserted sleeve is the samelength or longer than each previously inserted sleeve.

It may be advantageous in certain bone or in certain conditions that anon-cylindrical shaped implant be provided. For example, it may beadvantageous to provide an expandable implant that has a relatively flatsurface. Such flat surfaces may be advantageous in vertebral bodieswhere the flat surface or surfaces can be directed toward the inferioror superior end plates of the vertebral body. Such shapes may beadvantageous in long bones and other bones as well. Non-cylindricalimplant shapes contemplated include hexagonal, octagonal, square,trapezoidal, other polygonal shapes or asymmetrical shapes that mayprovide at least one relatively flat side or surface. FIGS. 10-11 showan expandable implant forming a square shape; while FIGS. 12-13 show ahexagonally shaped implant having eight relatively flat sides. Theexpandable implant 100″ in FIGS. 12-13 are formed with two spacers 124on each side of the hexagon with ribs 122 on the side edges. Elasticmembrane 126 connects the ribs and spacers together and permitsexpansion of the sleeves.

Non-cylindrical implants may be constructed or assembled with anon-cylindrical shaped core element that has at least one substantiallyflat side or surface. Unexpanded cylindrically shaped sleeves may beplaced over the non-cylindrically shaped core element. The expansionbetween the ribs and spaces may vary as the sleeve expands and changesto a non-cylindrical shape. The flexible struts between the ribs andspacers would expand more in some locations than in others, or theexpandable membranes or expandable bands between some ribs and spacerswould expand more than in others. Alternatively the sleeve may beprovided in a non-cylindrical shape where the spacing between the ribsand spacers already varies so that the sleeve is formed in a desirednon-cylindrical shape. Alternatively, the sleeve elements can be formedof ribs and spacers that do not extend around the entire circumferenceof the sleeve. As the sleeves are placed over the core element anasymmetrical implant may be created. Alternatively or additionally,non-uniform thick ribs and spacers, and/or curved exterior and interiorsurfaces on the ribs and spacers may be used to create the desired shapeand size of the expandable implant.

In use, a passageway is created to the bone to be treated and a passagemay be made into the bone where the implant is to be located. A drill ortrocar may be used to create the passage into the bone. Optionally, acavity may be formed in the bone by removing or compacting bone,preferably cancellous bone. A balloon expandable catheter may be used tocreate the cavity, or other instruments may be used to create the cavityby compacting bone or removing bone. Alternatively, only the passage maybe formed in bone without forming an enlarged cavity. An access tube orcannula may be inserted down through the soft tissue. The access tubealso may be inserted into the passage in the bone. The access tubepreferably has a sufficient inside diameter (cross-section) to permitthe insertion instrument and core element down the hollow bore providedin the access tube.

The core element is preferably attached to (threaded onto) the rod ofthe insertion instrument. The insertion instrument can be preloaded withsleeves prior to or after attachment of the rod to the core element. Theinsertion instrument and core element assembly together may be inserteddown the access tube and the core element placed in position in thepassage or cavity in the bone.

The plunger mechanism is activated to move the first sleeve 120 a overand onto the core element while the rod and barrel of the insertioninstrument remains stationary in the bone. If further expansion of theimplant is desired the plunger mechanism is operated to move the secondsleeve 120 b over the core element and under the first sleeve 120 a toprovide an implant with a larger diameter or cross-sectional size. Ifyet further expansion of the implant is desired the plunger mechanism isoperated again to place a third sleeve 120 c over the core element andunder the second sleeve 120 b to provide a still larger sized implant ofincreased diameter, or cross-sectional size (height and/or thickness).Placing additional sleeves 120 over the core element is continued untilthe implant is the desired size. As subsequent sleeves are inserted, theearlier inserted sleeves expand. The expanding of the sleeves and thusthe implant can fill the cavity created in the bone, or other tissue, ora space. Expanding of the sleeves and the implant may additionallycompact bone, preferably cancellous bone, depending upon the treatmentdesired. The expanding of the implant may also move bone and/or tissue.In one preferred embodiment the expanding of the implant may compactcancellous bone and move cortical bone to restore or place the bone intoits desired size, shape and position. For example, the implant may moveor compact cancellous bone in a vertebral body, and may further move thevertebral endplates to adjust the height and angle of the endplates.

After the implant is expanded to the desired size, the rod is detachedfrom the implant. Optionally, end cap 180 can be coupled to the proximalend 110 b of the implant 100. The end cap 180 may have a projection 185that extends into the bore 118 a of the core element. The projection 185may have threading to engage the threading in the core element, or maysimply snap fit into the bore 118 a by a flange (not shown) and shoulder(not shown). Other ways of connecting end cap 180 to the implant 100 arecontemplated. Different size end caps 180 may be provided so that theend cap may extend radially beyond the core element and prevent thesleeves from moving distally.

While the core element and insertion instrument have been described asbeing inserted down an access tube, it will be appreciated that theinsertion instrument and core member may be inserted directly throughthe skin without tissue retractors or cannulas, or can puncture the skindirectly, and additionally or alternatively, may be inserted over aguide wire into position.

Once the implant is positioned it may be drilled and tapped from anydirection to pass screws, nails, k-wires or other fasteners tosupplement the fixation with other hardware. For example, if placed in avertebral body, the sleeve implant can assist with plate fixation byhaving the sleeve drilled and tapped to receive one or more screws whichare inserted into the vertebrae to fix the vertebral plate in position.The same procedure of using the sleeve implant to supplement platefixation can be used in long bones, soft tissues or non-medicalapplications.

Furthermore, after the implant 100 is placed in bone, bone cement, bonechips or other biological material or polymeric material may be insertedinto the cavity or passage in the bone. Additionally, or alternatively,a plug, for example, formed of bone, may be inserted behind the implant100. The bone cement or other biologic or polymeric materials may beused in conjunction with the supplemental fixation discussed above andmay be inserted before, after or during the supplemental fixation.

The implant 100 and preferred minimally invasive surgical methodprovided by the present invention enables a surgeon to control theoriginal position and final expansion geometry of the implant 100because the implant 100 expands geometrically.

In one embodiment, the core element has a diameter or height ofapproximately 4 mm to approximately 8 mm and a length of approximately1.5 cm to approximately 2.5 cm, and the sleeve elements have an insidediameter or height of approximately 4 mm to approximately 8 mm, and alength of approximately 1.5 cm to approximately 2.5 cm, and a thicknessof approximately 1 mm to approximately 2 mm. Of course, different sizecore elements and sleeves may be provided as it will be appreciated thatdifferent size implants will be appropriate and desirable depending uponthe application, including, for example, the bone being treated. One ofskill in the art will know and appreciate the size of the implant, coreelements and sleeves appropriate for the different bone, fractures andconditions being treated.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concept thereof It is understood, therefore, that thisinvention is not limited to the particular embodiments disclosed, but itis intended to cover modifications within the spirit and scope of thepresent invention.

What is claimed:
 1. A kit configured to form an expandable implant fortreating bone, the kit comprising: a core element including a core bodythat defines a proximal end and a distal end spaced from the proximalend along a first direction, the core element further including a stopthat extends radially out from the core body proximate to the distalend, the core defining a core thickness along a second direction that isperpendicular to the first direction; and a plurality of radiallyexpandable sleeves configured to be sequentially insertable over thecore element along the first direction in such a manner that each of theplurality of expandable sleeves is configured to overlay another one ofthe plurality of expandable sleeves with respect to the second directionso as to form the expandable implant, each of the plurality ofexpandable sleeves defining a fixed thickness along the seconddirection, wherein the stop is configured to limit insertion of one ormore of the plurality of expandable sleeves along the first directionrelative to the core element.
 2. The kit of claim 1, wherein theplurality of radially expandable sleeves are configured to besequentially insertable over the core element along the first directionin such a manner that a first sleeve of the plurality of radiallyexpandable sleeves is inserted over the core element and eachsubsequently inserted sleeve is received between the core element andthe previously inserted sleeve such that the insertion of eachadditional sleeve causes each previously inserted sleeve to outwardlyexpand.
 3. The kit of claim 1, wherein the core body defines at leastone mating feature and each radially expandable sleeve defines at leastone mating feature such that the mating features of the core body andthe sleeves interdigitate with each other to thereby form the expandableimplant.
 4. The kit of claim 3, wherein the mating features of the corebody and the radially expandable sleeves are one of a projection and arecess that is configured to receive one of the projections so that theradially expandable sleeves interdigitate with each other and the coreelement.
 5. The kit of claim 4, wherein (i) the mating feature of thecore body is a recess, and (ii) each radially expandable sleeve definesa projection and a recess that is configured to receive a projection ofa subsequent radially expandable sleeve.
 6. The kit of claim 1, whereineach radially expandable sleeve is a one piece integral unit formed of aplurality of ribs that are elongate along the first direction, aplurality of spacers that are elongate along the first direction, and aplurality of flexible struts that connect adjacent ribs and spacers toeach other.
 7. The kit of claim 1 further comprising an end capattachable to the proximal end of the core body, the end cap beingconfigured to prevent at least the radially expandable sleeve that isadjacent the core element from moving along a direction that is oppositethe first direction when the end cap is attached to the core body. 8.The kit of claim 7, wherein the proximal end of the core element definesa threaded bore and the end cap includes a threaded projection that isconfigured to be received by the bore to thereby attach the end cap tothe core element.
 9. The kit of claim 1 wherein the radially expandablesleeves initially have a cylindrical shape and are expandable to anon-cylindrical shape.
 10. The kit of claim 1, wherein the expandableimplant has a thickness that expands with respect to the core thicknessan amount equal to a sum of the fixed thicknesses of each of theradially expandable sleeves that are sequentially inserted over the coreelement.
 11. A system for treating bone, the system comprising: a rigidcore element having an instrument engagement feature, the core defininga proximal end and a distal end spaced from the proximal end along afirst direction; an insertion instrument that includes a rod elementhaving a core element engagement feature that is configured to mate withthe instrument engagement feature to thereby selectably couple the coreelement to the insertion instrument; and a plurality of expandablesleeves that are configured to be advanced along the rod element andonto the core element, in such a manner that each of the plurality ofexpandable sleeves is configured to overlay another one of the pluralityof expandable sleeves along the core element with respect to a seconddirection that is perpendicular to the first direction.
 12. The systemof claim 11, wherein the insertion instrument further includes acannulated barrel and wherein the rod element is disposed within thecannulated barrel.
 13. The system of claim 12, wherein (i) theexpandable sleeves are configured to be placed in end-to-end fashionalong the rod element and within the cannulated barrel such that theexpandable sleeves are advanceable along the rod element and onto thecore element, and (ii) advancement of at least one additional expandablesleeve element along the rod element and between the core element and apreviously inserted expandable sleeve causes the previously insertedexpandable sleeve to radially expand such that the radius of the implantincreases as each additional expandable sleeve is applied about the coreelement.
 14. The system of claim 11, wherein the expandable sleeves havean expandable condition and an unexpanded condition wherein in theunexpanded condition the sleeve elements are substantially cylindricallyshaped and in the expanded condition the sleeves are non-cylindricallyshaped.
 15. The system of claim 14, wherein the expandable sleeves areconfigured to interdigitate with one another when the expandable sleevesare stacked on top of each other.
 16. A method of treating bone in aminimally invasive manner, the method comprising the steps of: insertinga core element that is attached to a rod element of an insertioninstrument into a cavity defined by the bone; advancing a firstexpandable sleeve along the rod element and onto the core element; andadvancing at least one additional expandable sleeve along the rodelement and onto the core element between the core element and thepreviously inserted expandable sleeve, thereby causing radial expansionof the previously inserted expandable sleeve.
 17. The method of claim16, further comprising the step of attaching the core element to the rodelement prior to inserting the core element into the cavity.
 18. Themethod of claim 16, further comprising the step of inserting an accesstube into soft tissue such that the access tube defines a passageway tothe cavity, wherein the inserting step comprises moving the core elementthrough the passageway.
 19. The method of claim 16, further comprisingthe step of detaching the rod element from the core element.
 20. Themethod of claim 19, further comprising the step of attaching a cap tothe core element after the rod element has been detached to thereby lockthe expandable sleeves on the core element.